Device recall
Z-2653-2011: First Breath Adult Face Tent (Non-latex) 50/CA Reorder Number: 001490 Face Tent…
FDA device recall · Class II · Smiths Medical
Key facts
| Recall number (Z-number) | Z-2653-2011 |
|---|---|
| Recall event | 57906 |
| Product | First Breath Adult Face Tent (Non-latex) 50/CA Reorder Number: 001490 Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of mask is used to deliver an aerosol mist to cool and moisturize the nasal passages or sinuses after… |
| Product code | BYG |
| Recalling firm | Smiths Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2018 |
| FEI number | 3002807908 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database